Hepatitis B virus genotyping detection reagent kit (PCR-fluorescence method) - NMPA Registration 国械注准20173400439
Access comprehensive regulatory information for Hepatitis B virus genotyping detection reagent kit (PCR-fluorescence method) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20173400439 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on August 06, 2021.
This page provides complete registration details including registrant information, province location (Shanghai), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
This product is used for the qualitative detection of hepatitis B and C viruses in the serum of hepatitis B patients.
该产品用于定性检测乙型肝炎患者血清中B、C型乙型肝炎病毒。
Nucleic acid extract A, nucleic acid extract B, PCR buffer, B-type probe, C-type probe, Taq enzyme, B/C strong positive control, type B positive serum control, type C positive serum control, negative control. (Please refer to the manual for details)
核酸提取液A、核酸提取液B、PCR缓冲液、B型探针、C型探针、Taq酶、B/C强阳性对照、B型阳性血清对照、C型阳性血清对照、阴性对照。（具体内容详见说明书）
Store at -20 °C with a valid date of 12 months.
-20℃保存，有效期为12个月。